05
Nov 2020

History of Helium Leak Detection

History of Helium Leak Detection

The First Helium Leak Detectors

The genesis for the use of helium as a method for leak detection can be traced back to the 1940’s and the Manhattan Project. The first atomic bomb created used uranium isotope 235, which is taken by way of separation from uranium-238. The separation was accomplished in a huge “diffusion” plant using microporous tubing as the diffusion medium and this process needed to be done in a manner that prevented any trace of moist ambient air in the process chambers. In essence, it was imperative that all the equipment be free of any leaks. Equipment of this size and magnitude had never before been tested to such and extreme leak detection specification. A number of various leak detection devices were tried, and they all proved unsuccessful as they could not meet the required standard for sensitivity. Eventually, a simplified mass spectrometer based on the Nier 60 spectrometer tube was chosen for leak detection and helium was the gas of choice used with it. It was determined that helium flow as sensitive as 10−6 std cm3 could easily be detected.

Major Improvements in Helium Leak Detection

In the 70+ years since the inception of the Manhattan Project, helium leak detectors have understandably been drastically improved. The size of an actual helium detector that in 1945 required a large scale, multi-story warehouse building, can now fit on a standard laboratory benchtop and the level of detection has been improved to levels that meet or exceed flows rates of 10−10–10−11 std cm3. With the inception of computers, operation of a helium detector has been fully automated. Based upon these developments, the use of helium as a medium for leak detection has become common and wide-spread practice and thus has a presence in almost every conceivable industry from refrigeration, semi-conductors, automotive and food and drug packaging components.

Modes of Operations using Helium Leak Detection

Conceptually, the principle of operations has not changed much in the past 50 years although, as noted, the size has been drastically reduced. The central piece of the helium leak detector is the cell in which the residual gas is ionised and the resulting ions accelerated and filtered in a mass spectrometer. Most of the current detectors use, as in the original design, a magnetic sector to separate the helium ions from the other gases. Permanent magnets are generally used to generate the magnetic field. The adjustment needed for the selection of the helium peak is made by varying the ion energy. At the highest sensitivity range, currents as low as femtoamperes have to be measured. This is achieved with the use of an electron multiplier in the most modern detectors. If the cell of a leak detector is not much different from the original design, the pumping system has considerably changed with the original diffusion pumps now being replaced by turbomolecular pumps or dry molecular-drag pumps. The sensitivity of the helium leak detector is given by the ratio between the helium flow through the leak and the partial pressure increase in the cell. In order to increase the sensitivity, the pumping speed of the tracer gas has to be reduced. This must be done without diminishing the pumping speed for the other gases (mainly water as leak detection usually takes place in unbaked systems) in order to keep the appropriate operating pressure for the filament emitting the ionising electrons. Selective pumping is therefore needed to provide a high pumping speed for water and a low pumping speed for helium

We hope that you have learned something regarding the history of helium leak detectors. In future installments, we will address various test methods and case studies that will provide more specific insight into the use of helium applied to the package leak testing needs of the pharmaceutical and life sciences industries.

Readmore...
helium leak detection, helium leak detector, operations using helium leak detection
211
04
Nov 2020

Applications of HeLD to Cartridge Package Development and Validation

Applications of HeLD to Cartridge Package Development and Validation

In a recent blog, we discussed the application of helium leak detection (HeLD) as part of a capping optimization study or assembly validation for glass and plastic vials. A defining characteristic of helium leak detection, instruments such as the SIMS 1284+ have sensitivity capable of measurement below the maximum allowable leakage limit (MALL) of many pharmaceutical and medical device products. This allows for study-based comparisons and data-informed decision making at a very fine scale. More importantly, these types of studies can be used to support regulatory documentation and in fulfillment of guidance such as USP <1207>.

While applications of this approach to vials are well established, if increasingly popular, very similar approaches can be taken for other common package systems used in the industry. Cartridges, which are frequently used as part of a device delivery system, are one such format. Similar to a traditional vial, one end of a cartridge is typically sealed with an elastomer-lined crimp. Compared to that of a 20mm or 13mm vial, cartridge crimp seals are relatively small and intricate. On the other end, a cartridge is typically sealed by an elastomeric plunger, similar to that which may be found on a syringe. Each of these unique sealing interfaces present specific challenges from a CCI perspective.

Considering the crimp interface of the cartridge, similar studies as for a vial can be performed to optimize and validate component choice as well as assembly parameters and processes. Comparative studies can be performed to choose the most robust cartridge-seal combination given machinability limits. Studies involving multiple crimp configurations, in conjunction with HeLD and RSF, can help elucidate a set of capping parameters that consistently yields an integral seal with low leakage. As with vials, it is possible that dimensional stack-ups, in conjunction with limitations in machinability, yield defects such as loose crimps, misaligned seals, stress cracking from high crimp force, etc. Characterizing these risks through quantitative, deterministic analyses can inform mitigation strategies and quality decision making about the assembly process. With final components and assembly parameters chosen, assembly validation using cartridges capped real-time can be performed, fulfilling best practices outlined through industry standard guidance such as USP <1207>.

Unlike the crimp-sealed end, the barrel end of a cartridge is less a function of an applied force. However, similar optimization and assembly validation practices apply. As with any package system requiring a high degree of leak protection, early on in the development process, the inherent integrity of the chosen product-package system should be evaluated, essentially answering the question: “Are these components, when mated optimally, capable of creating an integral seal?”. This extends to the choice of suitable barrel-plunger interfaces as well. Arguably, since the barrel-plunger interface is not a function of a controllable process such as crimping, inherent integrity evaluations become even more critical. The achieved seal will be primarily a function of the dimensional overlap between the cartridge inner diameter and the plunger outer diameter.

In a laboratory setting, consider a study designed to evaluate barrel-plunger samples paired at dimensional extremes. Within their respective dimensional tolerances, the widest barrel inner diameter paired with the smallest plunger presents the highest risk for leakage, as there may be insufficient or inconsistent compression of the plunger against the cartridge wall. On the other hand, consider the smallest barrel inner diameter paired with the widest plunger. In this case, it is critical to ensure proper function, lack of stress-related defects such as cracking or fitment-related issues risking leakage, such as mis-aligned plungers. A study exploring these dimensional extremes provides confidence that components, within their dimensional stack-up ranges, will provide integral seals. This can be further confirmed by assessing real-world cartridges assembled on the line.

This type of work can be performed at a production facility, using client-owned instrumentation or in-house contract services. Additionally, LDA’s sample filler allows for sample preparation at time of test, enabling analysis of samples previously produced and sealed, or transfer of samples between manufacturing and testing sites. With increasing regulatory scrutiny as well as risk in poor package development and validation practices, helium leak detection, as enabled by the LDA SIMS 1284+ system, is a versatile tool in generating a robust foundation of CCI data for modern package systems

Readmore...
SIMS 1284+, helium leak detection, application of helium leak detection
106
22
May 2019

Industrial Production Processes and Leak Detection Associates partner in key global markets

Industrial Production Processes and Leak Detection Associates partner in key global markets

EGG HARBOR TOWNSHIP, N.J. (PRWEB) MAY 22, 2019

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries’ is excited to announce that a formal partnership agreement with Industrial Production Processes (IPP) Ltd has been signed. The agreement will grant exclusive rights for IPP group to represent LDA in the countries of England and Ireland. With locations in Cork, Ireland and Worcestershire, UK, IPP is well positioned in both locations to meet the needs of LDA clients who are in need of helium-based leak testing instruments and systems and the ancillary services that go with them. IPP maintains of staff of 24 service and sales engineers that will be in the ready to serve existing and new clients. As a leading package system instrument and service provider in these geographic areas, IPP has the local knowledge and experience to enhance the already strong Leak Detection Associates’ brand.

“Global expansion is a key initiative of the new Leak Detection Associates management team and we are excited to partner with IPP to make this possible in Ireland and the UK,” commented Brian Mulhall, CEO of Leak Detection Associates. “I have known and worked with Jack Daly and the IPP group in previous settings and the team always brings a high level of knowledge, experience and client care to their work. They are a leading provider of package equipment and laboratory instruments in these countries and we are happy they will be our partners.”

Commented IPP Managing Director Jack Daly, “Partnering with LDA was an easy and natural decision as we are already well established in the relevant packaging instrument field and their technology allows the IPP team to better serve our client base with a broader product and service offering.”

IPP will serve as the exclusive product and service provider for Leak Detections Associates complete line of products and services. The current model SIMS 1284+ helium leak detection instrument is the only custom designed and manufactured helium leak testing instrument that meets the regulatory requirements of the pharma, biotech and medical device industries. In addition, LDA and IPP will offer a full suite of support services that will include custom designed change parts to address various container and package configurations, system parts and add-on options as well as local service, repair and qualification programs.

TO READ THE FULL PRWEB PRESS RELEASE PLEASE CLICK HERE

Readmore...
helium leak detection, industrial production processes, helium package leak detector, helium-based leak testing instruments
105
13
May 2019

Leak Detection Associates Announces Release of New Heliumleak.com Website

Leak Detection Associates Announces Release of New Heliumleak.com Website

EGG HARBOR TOWNSHIP, N.J. (PRWEB) MAY 13, 2019

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries’ is excited to announce the go-live of a completely new Heliumleak.com company website. The redesigned website aims to improve LDA’s ability to communicate directly with the marketplace; serving as a destination to learn LDA’s product and service offerings, news and events, but also as a knowledge center for those interested in helium leak detection applications and CCIT in general.

“For those first exploring any topic, whether it be CCI or unrelated, the first step will be to seek information online.” commented Brian Mulhall, CEO of Leak Detection Associates. “In redesigning LDA’s Heliumleak.com, this was kept in mind. In addition to more detailed descriptions of products, services, and applications of helium to specific package systems, the Resource Center will serve as an industry-leading destination for up-to-date information on all aspects of CCI. Blogs and Whitepapers will routinely be released discussing unique applications of helium leak detection and CCI in general, and an entire section is dedicated to topics such as FDA, EMA, USP, and ASTM guidance.”

The Products section now includes more detail about LDA’s flagship detector, the SIMS 1284+, but also will serve to highlight current and future complimentary offerings, such as LDA’s proprietary vial filling kit and Headspace Analyzing Module (HSAM), which allow for testing of pre-sealed vials. The redesigned services section now clearly highlights LDA’s 20+ years of experience in qualification, calibration, but also consultation, feasibility, and method development services. Uniquely, an entirely new section was added for Applications, which discusses helium-leak approaches for specific package systems, such as vials, pre-filled syringes, combination products, blisters, and more.

READ THE FULL PRWEB PRESS RELEASE

Readmore...
helium-based leak testing instruments, helium leak detection, leak detection
98

Popular Blogs

Tags

2019 PDA Container Closure Integrity Testing Workshop Presentation

Nov 03, 2020   |   284

The 2019 PDA Container Closure Integrity Testing Workshop in Gothenburg, Sweden, had the following presentation that was given as a 20 minute introduction to the use of helium leak detection for container closure integrity testing (CCIT).

Leak Detection Associates Announces New and Updated Helium Leak Detection System

Nov 01, 2020   |   280

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments is excited to announce the launch of its newest and most advanced helium leak detection system, the SIMS Model 1915 that is engineered incorporating industry-leading Agilent Technologies components and is custom designed to meet the stringent requirements of clients in FDA-regulated industries.

Leak Detection Associates Celebrates Major 2019 Milestones

Dec 27, 2019   |   262

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries is excited to celebrate the completion of its first calendar year under new management.

The Advantages of Using Helium for Leak Testing

May 13, 2020   |   219

The use of helium gas as a medium for leak testing dates back to the 1940’s.Using helium as the “tracer” gas enables the user to discover and measure extremely small leaks.

History of Helium Leak Detection

Nov 05, 2020   |   211

The genesis for the use of helium as a method for leak detection can be traced back to the 1940’s and the Manhattan Project. It was determined that helium flow as sensitive as 10-6 std?cm3 could easily be detected.
COPYRIGHT 2020, LDA, ALL RIGHTS RESERVED PRIVACY AND COOKIES
Popup